FDA scientists have had a chance to develop an assessment of the risks of BPA in food contact applications using a fuller body of low-dose studies and concluded last week that there’s some concern about the potential effects of BPA on the brain, behavior, and prostate gland of fetuses, infants and children (for a helpful analysis of the context of FDA’s decision, see Sarah Vogel’s post at The Pump Handle). Now, it’s time to look at what EPA is doing with respect to the ubiquitous endocrine-disrupting chemical.
In late September, Lisa Jackson announced that EPA’s Office of Pollution Prevention and Toxics would develop “action plans” for four chemicals or groups of chemicals, outlining potential future regulatory actions aimed at protecting the public and the environment from unreasonable risk. BPA was one of the candidates for an action plan, but when EPA released its four plans on December 30, BPA’s was not among them. EPA’s reason for delaying the BPA action plan was that it was waiting on FDA’s newest analysis and the results of $30 million worth of new studies being conducted under various grants from NIEHS.
Full textOver the weekend, the Associated Press ran a story on the results of its enterprising investigation into the toxic content of children’s jewelry imported from China. Pressed to abandon the use of toxic lead in toys and jewelry, manufacturers have apparently begun using an even more dangerous metal, cadmium, which can cause neurological damage – brain damage – to children and give them cancer. AP tested 103 pieces of jewelry bought in American stores within the last few months, and found that 12 percent contained at least 10 percent cadmium. One item, a cute little Rudolph the red-nosed reindeer trinket, was 91 percent cadmium.
Addressing the question that leaps to mind – How did these extraordinarily dangerous trinkets get onto store shelves in the first place? – reporter Justin Pritchard writes these utterly terrifying and completely truthful words:
A patchwork of federal consumer protection regulations does nothing to keep these nuggets of cadmium from U.S. store shelves. If the products were painted toys, they would face a recall. If they were industrial garbage, they could qualify as hazardous waste. But since there are no cadmium restrictions on jewelry, such items are sold legally.
Of course, this is just the latest in a series of startling tales of dangerous products making it to market in the United States – poisoned peanut butter, toxic drywall, lead-painted toys, and more. Not to put too fine a point on it, but such products often kill people – sometimes immediately, from acute exposure to toxins, and sometimes over a longer period of time by way of cancer. If folks are lucky, their lives simply become miserable, with headaches, nausea, respiratory and heart problems a daily occurrence.
Full textCPRBlog asked some of our regular bloggers to give us some suggestions for the high and low points of the regulatory year. We began by taking the Bush Administration’s “midnight regulations” off the table, so that we could focus in on the Obama Administration’s impact to date. CPR Policy Analyst Matt Shudtz offers up a number of items, below, focusing on the positive:
At OSHA, several high points:
The leadership of David Michaels (as Assistant Secretary, the head of OSHA) and Jordan Barab (as Deputy Assistant Secretary), both of whom seem intent on putting OSHA back on task – protecting workers – after years of agency wheel-spinning.
OSHA’s enforcement sweep of construction sites in Texas, in which the agency brought inspectors from other regions to conduct unannounced inspections. Actual enforcement of the laws! Texas earned the honor because it has the highest rate of construction fatalities in the nation.
Assessing meaningful fines. OSHA proposed the largest fine in its history this year. Under the proposal, BP would pay $87.4 million for safety violations and its failure to correct hazards at the Texas City refinery, where an explosion killed 15 workers and injured 170 in 2005.
Yesterday came and went with no announcement from the FDA on the safety of BPA in food packaging. The agency had created a self-imposed November 30 deadline for releasing a new finding, and in the intervening months, a number of new studies on the health effects of BPA have been released and FDA has brought in an outside expert to head up the review. These developments have understandably slowed the review process.
The question before FDA is whether BPA is safe for its intended use in food contact applications -- the lining inside cans, for example. So Kaiser Permanente’s recent headline-grabbing study that showed an increased likelihood of erectile dysfunction and problems ejaculating among workers who were highly exposed to BPA in a Chinese plant might not be very useful in making that determination. But the many studies showing correlations between various exposures to BPA and other adverse health effects might be more important.
As Meg Kissinger reports in the Milwaukee Journal-Sentinel, FDA’s review panel – now headed by Lynn Goldman of the Johns Hopkins School of Public Health, a renowned expert on endocrine-disrupting chemicals – must make its safety determination amidst a whirlwind of other developments, including voluntary restrictions on certain uses of BPA by the chemical’s manufacturers, local laws banning BPA use in baby bottles, and petitions from public health NGOs for new product labels, warnings, and temporary bans on specific uses of BPA.
The intertwined policy developments and evolving science on BPA’s toxicology have created a difficult environment for FDA to communicate a clear statement to the public about the health concerns connected to BPA. But slow reactions to experts’ warnings on public health threats have plagued FDA in recent years (e.g., suicides linked to antidepressants, dangers posed by children’s use of over-the-counter cough and cold medicines). The BPA review presents an opportunity for FDA to show it can be on the leading edge for a change.
Full textAs the recession grinds on, financial news continues to grab front-page headlines. The national deficit is a central flashpoint for controversy, triggering debate on the appropriate balance between spending today and increasing our children’s growing mountain of debt. In the midst of this battle, it is easy to overlook another looming problem: the growth of the environmental deficit. Overall, we are spending down the planet’s “natural capital” at unsustainable rates. As the nation’s most thoughtful minds address our economic woes, their wisdom provides three important lessons for environmental sustainability. The moment is particularly ripe for such analysis as the international community struggles with the overwhelming issue of climate change, certainly a key to achieving any sort of sustainable environmental future.
Re-regulation to promote responsibility: Even as taxpayers bailed out financial institutions deemed too big to fail, executives received huge bonuses. Growing outrage has prompted a call for increased governmental oversight, reversing the nearly three-decade deregulatory agenda initiated by Ronald Reagan, who mocked durable federal agencies and programs as “the nearest thing to eternal life we’ll ever see on this earth.” Even Alan Greenspan, former chairman of the Federal Reserve and a staunch supporter of deregulation, admitted in 2008 that his “whole intellectual edifice” had collapsed and that he was in “shocked disbelief” to discover that his faith in the unregulated free market had been woefully misplaced.
In the environmental realm, this deregulatory frenzy most recently manifested itself through a spate of “midnight regulations” promulgated by the Bush administration during its final months. These agency rules—largely invisible to the general public—dismantled numerous important environmental safeguards. For example, in the name of “streamlining” the permitting process for coal mines, one new rule would have allowed over 1,000 miles of Appalachian streams to be filled with the debris from so-called “mountaintop removal” mining, as entire peaks are blasted off to expose underlying coal deposits. A second late-term rule, ostensibly enacted to “clarify” existing requirements and to produce a process that is “less time-consuming and a more effective use of our resources,” would have allowed federal agencies to conduct activities that may harm threatened or endangered species without even consulting federal wildlife experts. In all, the Bush administration rushed through dozens of such regulations.
Full textEarlier this month, EPA released for public comment a new white paper on probabilistic risk assessment, marking the Obama Administration’s first major foray into the contentious debate about EPA's evolving risk assessment methods. Back in May, EPA Administrator Lisa Jackson announced changes to the way the Office of Research and Development (ORD) will update risk assessments for the IRIS database, but that announcement was made without any real public input and it only implicated the inner workings of one program office (albeit an important one). The public comment period on the new white paper presents the first opportunity for the various stakeholders who usually weigh in on EPA’s risk assessment policies to have some say in the new administration’s policies.
The new white paper, Using Probabilistic Methods to Enhance the Role of Risk Analysis in Decision Making, focuses on one of the fundamental problems in regulatory risk assessment – how should risk assessors and risk managers address the uncertainty and variability intrinsic to the risk assessment process?
The most straightforward way to answer that question, and EPA’s approach in many situations, is to use default assumptions. When the pesticides program staff is working on setting a limit for pesticide residue on apples, they can use a standard assumption about the number of apples a person eats. Or when ORD staff updates IRIS profiles, they can assume a linear dose-response relationship for a suspected carcinogen’s toxicity. But as scientific knowledge about certain parameters and models used in risk assessments grows, default assumptions might legitimately be replaced by data collected in the real world. Recognizing that every parameter and model used in a risk assessment has some inherent level of uncertainty, and that variability in the population can have a significant impact on risk determinations, risk assessors can use probabilistic data to replace point estimates of specific parameters or generic model assumptions.
Full textOn Monday, the big news out of FDA was the announcement that they’re going to publish a new assessment of the risks posed by BPA in food packaging, due out by the end of November. Jesse Goodman, FDA’s Chief Scientist, made the announcement at a meeting of the agency’s Science Board, which also heard two presentations by scientists from different offices within FDA working on the new assessment.
Last year, FDA formed a task force to assess the risks of BPA and the task force quickly concluded that “there is a large body of evidence that indicates that FDA-regulated products containing BPA currently on the market are safe and that exposure levels to BPA from food contact materials, including for infants and children, are below those that may cause health effects.” Given the rapid development of new studies on BPA in the diet, it’s a good thing that FDA is taking another comprehensive look at the available science. In the development of their new assessment, FDA ought to use a “weight-of-the-evidence” approach to their work and give due consideration to each study’s funding source and the researchers’ freedom to design and publish their work without sponsor interference.
Full textCPR Member Scholar Thomas McGarity testified this afternoon at a hearing of the Senate Committee on Health, Education, Labor, and Pensions on the issue of medical device safety (written testimony, press release).
Currently, individuals injured by a faulty medical device generally cannot sue the device manufacturer in state courts if that device was fully approved by the FDA, even if the manufacturer was aware of new research showing faults in the product. The Senate is considering a bill that would exempt state common law claims from the express preemption clause in the Medical Device Amendments to the Food, Drug and Cosmetics Act. The House is considering a similar bill.
"The implicit assumption in preempting medical device injury claims in state courts is that the FDA can and is performing its job perfectly, but that's just not the case," McGarity says. "Common law still has an important role to play in providing justice to victims of defective products, and the public deserves that protection."
The hearing today was packed, including with numerous individuals who had been harmed by faulty medical devices.
A summary of McGarity's testimony is after the jump. For more on the issue, see Matt Shudtz's previous post.
Full textThe Chesapeake Bay watershed covers 64,000 square miles, measuring 200 miles in length and 35 miles at its widest point. The watershed is one of the most beautiful and economically productive in the world. Tourism, which depends to a large extent on the preservation of pristine environmental conditions, contributes billions of dollars to the economies of Delaware, Maryland, Pennsylvania, and Virginia. As Shana Jones recently wrote on CPRBlog, the Bay is plagued by so-called "nutrient loading," a condition where a river or stream is choked with organic matter discharged from sewage treatment plants and manufacturing facilities or washed into the water by rainwater runoff from hog and chicken farms, other agricultural lands, and urban centers.
Full textOn Wednesday, Representative Henry Waxman introduced a comprehensive "Food Safety Enhancement Act" (116-page discussion draft) to repair part of a federal food safety protection regime that has been badly broken for several decades. Waxman was joined by Representatives Diana DeGette, John Dingell, Frank Pallone, Bart Stupak, and Betty Sutton; the House Energy and Commerce Committee will hold a hearing on the issue on Wednesday, June 3.
A key problem with the current system is that it employs regulatory tools developed during the early twentieth century to address the risks posed by a radically different twenty-first century food production and delivery system.
The existing regime is built upon the assumption that state and local governments can adequately address the risks of a largely local food supply with occasional assistance from a federal Food and Drug Administration that focuses primarily on animal feeds, food additives and a modest quantity of (mostly exotic) imported food. But we now live in a world in which much of our fresh produce travels long distances (often from other countries) and the processed foods that we consume can come from huge production complexes or tiny "Mom and Pop" facilities located almost anywhere.
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